Pharmaceuticals

Last Updated on September 17, 2026

The following guidelines are intended to help the industry and other applicants to meet the regulatory requirements related to pharmaceutical products.

1. Drug Manufacturing License

• Guidance on Establishment of Pharmaceutical Unit and Post License Changes (2nd Edition) (Effective Date: 01 Nov 2024)

2. Drug Registration

• Guidance on the Registration Pathways for Pharmaceutical and Biological Drug Products for Human Use
• Guidance Document For Submission Of Application On FORM 5-F (CTD) For Registration Of Pharmaceutical Drug Products For Human Use .
• Guidance on Preparation of Summary of Product Characteristics (SmPC)
• Guideline on Registration requirements to establish the interchangeability of Pharmaceutical Drug Products
• Guidance on Labeling and Packing of Drugs
• Guidance on Patient Information Leaflet (PIL)
• Guidelines on Good Review Practices
• Frequently asked questions about Form 5F (Common Technical Documents)

3. Post Approval Variations of Drugs

• Post Registration Variation Guidelines For Pharmaceutical and Biological Products

4. Non Routine Registration pathways for Drug Registration

• Priority Review and Accelerated Approval of Registration / Market Authorization

5. Reliance Mechanism

• Reliance Mechanism in Regulatory processes, A DRAP’s approach on Good Reliance Practices

6. Appeals Against Regulatory Decisions

• Guidelines for Filling an Appeal Against the Decisions of Statutory Bodies (e.g. Registration Board)